EnCompass Content System for MDR/IVDR Compliance & Savings
EnCompass is a modular automation solution for MDR/IVDR content compliance that delivers 50% cost and turnaround savings. Each component can be employed individually or together, based on specific client requirements. The full system includes:
XML Content
Management
Supports increased content volume and velocity due to MDR/IVDR requirements. “We process ten times more content with the same headcount thanks to XML technology from TransPerfect” – Medtronic
Translation Process
Automation
Including AI-AssistTM translation automation and business intelligence reporting. Supports increased translation volumes due to MDR/IVDR requirements.
UDI-Enabled
Technology
Supports direct-to-user labeling and publication and master data management , helps satisfy EU UDI requirements.
"...it's no exaggeration to say that systems like this are why UDI was created."
~ Jay Crowley, former FDA Senior Advisor for UDI and VP of UDI for USDM
See it in Action!
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Master Data Management
The EnCompass UDI scanning app ensures your product is correctly labeled and registered in FDA's GUDID as well as manufacturers' PLM systems. Our tested approach helped one manufacturer solve a $3 billion inventory management and regulatory compliance issue and saved tens of millions of software costs in the process.
